Federal Health Policy Update for Tuesday, January 11

The following is the latest health policy news from the federal government as of 2:30 p.m. on Tuesday, January 11.  Some of the language used below is taken directly from government documents.

Provider Relief Fund

  • HHS has updated its FAQ for reconsideration requests involving Phase 4 and rural hospital payments.  Find the updated FAQ here.

Department of Health and Human Services

COVID-19

  • HHS announced that beginning January 15, individuals with private health insurance coverage who purchase an over-the-counter COVID-19 diagnostic test authorized, cleared, or approved by the FDA will be able to have those test costs covered by their insurance.  Insurers will be required to cover eight free over-the-counter home tests per covered individual per month.  Over-the-counter test purchases will be covered in the commercial market without the need for a health care provider’s order or individualized clinical assessment and without any cost-sharing requirements such as deductibles, co-payments or coinsurance, prior authorization, or other medical management requirements.  Learn more about how this process will work from this HHS news release; a CMS explanation of how to get free tests; and an HHS FAQ.

Health Policy Update

  • HHS’s Health Resources and Services Administration (HRSA) has updated comprehensive preventive care and screening guidelines for women and for infants, children, and adolescents.  Under the Affordable Care Act, certain group health plans and insurers must provide coverage with no out-of-pocket cost for preventive health services within these HRSA-supported comprehensive guidelines.  Learn more about the updated guidelines in this HHS news release and the updated guidelines.
  • HHS’s Office of the National Coordinator for Health Information Technology (ONC), in collaboration with standards development organizations and health IT stakeholders, has released the Project US@ Technical Specification Final Version 1.0.  This new specification is a unified, cross-standards, health care specification that could be used across the health care industry for representing patient addresses (mailing, physical, billing, and more) to improve patient matching. Patient matching, and specifically how patient addresses are represented, has long been viewed as a critical component of nation-wide interoperability and the nation’s health IT infrastructure.  ONC encourages state and federal agencies, public health organizations, payers, health IT developers, research organizations, health care providers, and others to consider adopting and implementing the final specification.  Learn more from this HHS news release and see the Project US@ web page to learn more about the project and for a link to the final technical specification.
  • HHS’s Office of Minority Health has extended to March 11 the deadline for nominations for delegates for the Center for Indigenous Innovation and Health Equity Tribal Advisory Committee.  Learn more from this Federal Register notice.
  • HHS’s Office of the Assistant Secretary for Planning and Evaluation has published a new issue brief, “Access to Preventive Services without Cost-Sharing:  Evidence from the Affordable Care Act,” that summarizes the Affordable Care Act’s preventive services provisions for private health coverage, Medicare, and Medicaid; provides updated estimates of the number of people benefiting from these provisions nationally; and examines evidence on trends in utilization of preventive services and outcomes since the Affordable Care Act’s preventive services coverage requirements went into effect.  Find the report here.

Centers for Medicare & Medicaid Services

Health Policy Update

  • Medicare will begin funding 1000 new medical residency positions beginning in FY 2023.  For information about how to apply for those positions, go here (and scroll down to “Section 126: Distribution of Additional Residency Positions”).  The deadline for applications for FY 2023 positions is March 31, 2022.
  • CMS has issued a proposed rule to revise Medicare Advantage Part C and Medicare Prescription Drug Benefit Part D regulations to implement changes involving marketing and communications, past performance, star ratings, network adequacy, medical loss ratio reporting, special requirements during disasters or public emergencies, and pharmacy price concessions.  This proposed rule also would revise regulations addressing dual eligible special needs plans (D-SNPs), other special needs plans, and cost contract plans.  According to CMS, the proposed rule would lower out-of-pocket prescription drug costs for beneficiaries with Medicare Part D; improve price transparency and market competition; improve beneficiaries’ experiences with Medicare Advantage and Part D, with a strong emphasis on individuals who are dually eligible for Medicare and Medicaid; and hold Medicare Advantage and Part D plans to a higher standard in offering benefits and improve health equity in the programs.”  Learn more about the proposed rule from this CMS news release, a CMS fact sheet describing the rule in greater detail, and the proposed rule itself.  Interested parties have until March 7 to submit written comments.
  • Included in this same proposed rule is a request for comments as CMS assesses the impact of Medicare Advantage organizations’ prior authorization requirements for patient transfer on a hospitals’ ability to effectively manage resources and provide appropriate and timely care during a public health emergency.  Learn more about this request from this excerpt from the proposed rule.
  • CMS has informed nursing home operators that it will introduce data on nursing home staff turnover and weekend staffing to the Care Compare website in January of 2022 and the Nursing Home Five Star Quality Rating System in July 2022.  Learn more, including the rationale for including this information, from this memo from CMS to nursing home operators.
  • CMS’s Center for Medicare and Medicaid Innovation (CMMI) has published a list of the initial participants in its Kidney Care Choices Model, which was launched on January 1.  Learn more about the model here and find a list of the participants here.
  • CMMI has published evaluation and savings reports for four of the 13 states that participate in its Financial Alignment Initiative for Medicare-Medicaid Enrollees program.  Go here to learn about the program and find links to the reports.

COVID-19

Centers for Disease Control and Prevention

  • The CDC has updated its guidance on the differences between quarantine and isolation and who needs to quarantine or isolate, and for how long, based on different types of exposure to or infection with COVID-19.  Find this update here.
  • The CDC has posted new information about the need for COVID-19 vaccinations and boosters for those who are immunocompromised, including advice that some such people receive an additional primary vaccine before receiving a booster shot.  Find that guidance here.
  • The CDC has updated its COVID-19 vaccination recommendations for children and teens.
  • It is already known that COVID-19 infection is associated with worsening of diabetes symptoms and that persons with diabetes are at increased risk for severe COVID-19.   It also is believed that COVID-19 may induce newly diagnosed diabetes.  Now, the CDC has published new research indicating that persons under the age of 18 with COVID-19 were more likely to receive a new diabetes diagnosis more than 30 days after infection than were those without COVID-19 and those with pre-pandemic acute respiratory infections.  Go here to see the CDC’s report.
  • The CDC has updated its information about possible side effects from COVID-19 vaccines.
  • The CDC has published new research that finds that the estimated effectiveness of two doses of Pfizer vaccine against multisystem inflammatory syndrome in children (MIS-C) was 91 percent.  Among critically ill COVID-19 MIS-C patients requiring life support, all were unvaccinated.  Go here to see the CDC’s report.
  • The CDC has updated its infection prevention and control assessment tool for nursing homes preparing for COVID-19.
  • The CDC has posted updated information about Operation Expanded Testing, which seeks to increase access to testing nationwide, especially for communities that have been disproportionately affected by the COVID-19 pandemic.  The program provides no-cost testing to child care centers, K-12 schools, historically black colleges and universities, under-resourced communities, and congregate settings, such as homeless shelters, domestic violence and abuse shelters, non-federal correctional facilities, and other qualified sites.  The program can perform millions of tests through July 1, 2022, with contractor-provided laboratory services that include specimen collection supplies, shipping materials, laboratory testing, and results reporting.  Recipient sites contribute staff to collect specimens.  Learn more from this CDC resource.
  • The CDC is seeking nominations for individuals to serve on its Advisory Committee on Breast Cancer in Young Women.  Nominations are due February 28.  Learn more from this Federal Register notice.

Food and Drug Administration

  • The FDA has amended the emergency use authorization for the Moderna COVID-19 vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.  The previous standard was six months.  Learn more from this FDA news release.

Medicare Payment Advisory Commission (MedPAC)

  • The Government Accountability Office is accepting nominations for individuals to serve as MedPAC commissioner beginning in May of this year.  Letters of nomination and resumes are due February 11.  Learn more from this Federal Register notice.

Congressional Research Service

  • A new Congressional Research Service study, “Occupational Safety and Health Administration (OSHA):  COVID-19 Emergency Temporary Standards (ETS) on Health Care Employment and Vaccinations and Testing for Large Employers,” reviews OSHA’s authority to propose such a requirement, its promulgation of the requirement, legal action in response to its release, and its eventual withdrawal.  Find the study here.

Stakeholder Events

CDC – Clinical Outreach Communication Activity – January 12

Through its Clinical Outreach Communication Activity program, the CDC will hold a webinar on “What Clinicians Need to Know About the New Oral Antiviral Medications for COVID-19” on Wednesday, January 12 at 2:00 p.m.  Go here to learn more about the webinar, its purpose, the individuals who will be presenting, and how to participate.

MedPAC – January 13-14

The Medicare Payment Advisory Commission (MedPAC) will hold its next public meeting on January 13 and 14.  Go here for a meeting agenda and information about virtual participation.

MACPAC – January 20-21

The Medicaid and CHIP Payment and Access Commission (MACPAC) will hold its next public meeting on January 20 and 21.  Watch this space for a meeting agenda and information about virtual participation.

Federal Health Policy Update for Thursday, January 6

The following is the latest health policy news from the federal government as of 2:45 p.m. on Thursday, January 6.  Some of the language used below is taken directly from government documents.

Provider Relief Fund

The White House

Department of Health and Human Services

COVID-19 Hospital Data Reporting Requirements

  • HHS has written to health care providers to inform them of changes in its COVID-19 hospital data reporting requirements guidance; it has suspended reporting on some data elements and added some new ones.  The letter summarizes the changes, lists dates and times for webinars to learn about and ask questions about the changes, and offers telephone numbers and emails for support.  Find the letter here and find the revised reporting requirements here; changes in those requirements are highlighted.  HHS provided a preview of these changes to state officials; find its presentation to the states here.

COVID-19

  • HHS has amended a past COVID-19-related emergency declaration to authorize licensed pharmacists and pharmacy interns in good standing to order and administer flu vaccines in states in which they are not currently licensed and for such individuals to have liability protection under the Public Readiness and Emergency Preparedness (PREP) Act.  See the amended order in this Federal Register notice.

Health Policy Update

  • HHS’s Health Services and Resources Administration (HRSA) offers a number of funding opportunities with application deadlines in the coming weeks.  Go here to learn more about the various programs, what they offer, who can apply, and when applications are due.

Centers for Medicare & Medicaid Services

Health Policy Update

  • CMS has issued guidance to states and health insurers on state external review processes regarding requirements in the No Surprises Act, the federal surprise medical billing law that took effect on January 1.  See that guidance here.
  • CMS has published the latest edition of MLN Connects, its online newsletter with information about Medicare reimbursement issues.  The new issue includes items about changes in how Medicare Advantage plans will submit claims for monoclonal antibody treatments, the updated ambulatory surgical system payment system, a revised enrollment application for Medicare-covered opioid treatment, and more.  Go here to see the latest edition of MLN Connects.
  • CMS is seeking nominations for individuals to serve on several of its technical panels:  its technical expert panel for the Measurement Gaps and Measure Development Priorities for the Skilled Nursing Facility Value-Based Purchasing Program; for the CMS Quality Measure Development Plan and Quality Measure Index; and for its Dialysis Facility Quality of Patient Care Star Ratings Technical Expert Panel.  All of the nominations are due in the next few weeks.  Go here for further information about the individual panels, project summaries, and nomination criteria and deadlines.

Centers for Disease Control and Prevention

  • The CDC has updated its recommendation for when many people should receive a booster shot, shortening the interval from six months to five months for people who received the Pfizer vaccine.  This means that people can now receive an mRNA booster shot (Pfizer or Moderna) five months after completing their Pfizer primary series.  The booster interval recommendation for people who received the Johnson and Johnson vaccine (two months) and the Moderna vaccine (six months) has not changed.  Learn more from this CDC news release.
  • The CDC has endorsed its Advisory Committee on Immunization Practices’ recommendation to expand eligibility of booster doses to those 12 to 15 years old.  The CDC now recommends that adolescents ages 12 to 17 years old should receive a booster shot five months after their initial Pfizer vaccination series.  Find that announcement here.
  • The CDC now recommends that moderately or severely immunocompromised children between five and 11 years of age receive an additional primary dose of vaccine 28 days after their second shot.  At this time, the CDC has authorized only the Pfizer vaccine for this age group.  Learn more from the same CDC news release.
  • The CDC has updated its general guidance on COVID-19 vaccines and boosters for people who are moderately or severely immunocompromised.
  • The CDC has posted an explanation of why it has shortened its isolation and quarantine recommendations for individuals who are asymptomatic and mildly ill with COVID-19.  See the explanation here and the revised recommendations here.
  • The CDC has updated its overview and safety information about the Pfizer COVID-19 vaccine.
  • The CDC has updated its guidance on when people should be tested for COVID-19, when they do not need to be tested, and what they should do based on the results of such tests.
  • The CDC has published research on severe outcomes from COVID-19 among people who completed a primary vaccination regimen.  The research found that risk factors for severe outcomes included age 65 years or older, an immunosuppressed state, and six other underlying conditions.  All persons with severe outcomes had at least one risk factor; 78 percent of persons who died had at least four.  Go here to see the CDC’s report.

Food and Drug Administration

  • The FDA has approved an abbreviated new drug application for albuterol sulfate inhalation solution, which is used for the relief of bronchospasm in patients two to 12 years of age with asthma.  This preparation is sometimes used in the treatment of COVID-19.  See the FDA announcement of this approval here and technical information about albuterol sulfate here.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • The Government Accountability Office (GAO) is now accepting nominations for individuals to serve as MACPAC commissioners.  Learn more from this Federal Register notice.  Nominations are due by January 27.
  • MACPAC has published the new issue brief “Medical Loss Ratios in Medicaid Managed Care,” which provides an overview of federal capitation rate setting standards and specific guidance regarding the medical loss ratio for Medicaid managed care plans and describes variations among the states that employ Medicaid managed care.  Find it here.

Stakeholder Events

MedPAC – January 13-14

The Medicare Payment Advisory Commission (MedPAC) will hold its next public meeting on January 13 and 14.  Watch this space for a meeting agenda and information about virtual participation.

MACPAC – January 20-21

The Medicaid and CHIP Payment and Access Commission (MACPAC) will hold its next public meeting on January 20 and 21.  Watch this space for a meeting agenda and information about virtual participation.

 

Federal Health Policy Update for Monday, January 3

The following is the latest health policy news from the federal government as of 2:45 p.m. on Monday, January 3.  Some of the language used below is taken directly from government documents.

The White House

  • President Biden has issued a memorandum to the Secretary of Health and Human Services, the Secretary of Homeland Security, and the Administrator of the Federal Emergency Management Agency on maximizing assistance to respond to COVID-⁠19.  Among other things, the memorandum calls for FEMA to provide emergency and disaster assistance, to establish or expand COVID-19 testing sites at the request of state governments, and to underwrite the full costs it incurs in such efforts.  Learn more from the memorandum.
  • The White House has posted a transcript of the December 29 press briefing given by its COVID-19 response team and public officials.

Provider Relief Fund

  • The Provider Relief Fund reporting portal is now open for reporting period 2 and will remain open through March 31, 2022.  Go here for more information about what organizations do and do not need to report and how to do so.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy Update

  • CMS’s Center for Medicare and Medicaid Innovation has a “Most Favored Nation Model” that seeks to test a way to lower prescription drug costs by paying no more for high-cost Medicare Part B drugs and biologicals than the lowest price that drug manufacturers receive in other, similar countries. The program was schedule to begin in 2021 but was delayed when a federal court issued a preliminary injunction against that implementation.  Between the court’s ruling and stakeholder feedback, CMMI has decided to withdraw its Most Favored Nation Model and did so in this Federal Register notice.  Additional information can be found on CMMI’s Most Favored Nation Model web page.

Department of Health and Human Services

Health Policy Update

  • HHS is working with states to promote access to Medicaid services for people with mental health and substance use disorder crises by giving states a new option for supporting community-based mobile crisis intervention services for individuals with Medicaid through newly available federal funds.  The American Rescue Plan grants CMS new authority to provide states with additional resources and tools to enhance these programs, including additional federal funding to states for qualifying mobile crisis intervention services for three years.  This new Medicaid option also offers flexibility for states to design programs that work for their communities, allowing states to apply for this new option under several Medicaid authorities.  Learn more from this HHS news release and this guidance letter CMS has sent to state Medicaid directors.
  • HHS has published a Notice of Benefit and Payment Parameters 2023 Proposed Rule that seeks to make it easier for consumers to find affordable, comprehensive health coverage.  Among other steps, the proposed rule seeks to advance standardized plan options, implement network adequacy reviews, strengthen access to essential community providers, and prohibit discriminatory practices.  Learn more from this HHS news release, this HHS fact sheet, and the proposed rule itself.  Interested parties have until January 27 to submit formal written comments.

Occupational Safety and Health Administration (OSHA)

  • In June, OSHA adopted a “Healthcare Emergency Temporary Standard” to protect workers from COVID-19 in settings where they provide health care or health care services, doing so with the expectation that this standard would be formalized in regulation within six months.  Now, OSHA has announced that while the regulation still has not been finalized it “…will vigorously enforce the general duty clause and its general standards, including the Personal Protective Equipment (PPE) and Respiratory Protection Standards, to help protect healthcare employees from the hazard of COVID-19” while modifying certain other aspects of the standard.  Learn more about the standard and the ways in which the agency intends to enforce and modify it in this OSHA statement.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has amended its emergency use authorization (EUA) for the Pfizer COVID-19 vaccine to expand the use of a single booster dose to include use in individuals 12 through 15 years of age; to shorten the time between the completion of the original Pfizer vaccine regimen and a booster dose to at least five months; and to allow for a third primary series dose for certain immunocompromised children five through 11 years of age.  Learn more from this FDA news release.
  • The FDA has updated its EUA for COVID-19 convalescent plasma by placing new limits on its use.  See the announcement here and the revised EUA here.
  • The FDA is inviting industry organizations to participate in the selection of non-voting industry representatives to serve on certain panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health by nominating such individuals in writing.  The agency also seeks nominations for non-voting industry representatives to serve on certain device panels.  Learn more from this Federal Register notice.  The deadline for nominations is February 2.

Stakeholder Events

HHS Office of the Assistant Secretary for Preparedness – January 6

HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR) and Project ECHO will hold a “COVID-19 Clinical Rounds: A Peer-to-Peer Virtual Community of Practice” event on Thursday, January 6 at 12:00 (eastern).  COVID-19 Clinical Rounds are resource webinars intended for consultant physicians involved in critical care practice, fellows, residents, pharmacists, nursing staff, nurse practitioners, physician assistants, respiratory therapists, and allied health staff.  Go here to register for the January 6 event and find recordings of previous events here.

MedPAC – January 13-14

The Medicare Payment Advisory Commission (MedPAC) will hold its next public meeting on January 13 and 14.  Watch this space for a meeting agenda and information about virtual participation.

MACPAC – January 20-21

The Medicaid and CHIP Payment and Access Commission (MACPAC) will hold its next public meeting on January 20 and 21.  Watch this space for a meeting agenda and information about virtual participation.

Federal Health Policy Update for Thursday, December 16

The following is the latest health policy news from the federal government as of 2:45 p.m. on Thursday, December 16.  Some of the language used below is taken directly from government documents.

Provider Relief Fund

  • HHS’s Health Resources and Services Administration (HRSA) is releasing $9 billion in phase 4 Provider Relief Fund grants.  Payments will average $58,000 for what HHS is calling “small” providers, $289,000 for medium providers, and $1.7 million for large providers.  Learn more about the release of these funds from this HHS news release and go here for an explanation of how the agency calculated the payments.  The remainder of Phase 4 funding is expected to be distributed in January.
  • HRSA has updated its FAQ for its provider relief programs:  the Provider Relief Fund and American Rescue Plan rural payments.  The updated FAQ includes new information about reporting on mergers and acquisitions, reporting patient metrics, reporting on state and federal tax credits, and more.  The 12 new and modified questions, all dated 12/9/2021, can be found on pages 3, 10, 14, 15, 18, 34, and 36 of the updated Provider Relief Fund FAQ.

The White House

  • The Biden administration has issued an executive order on “Transforming Federal Customer Experience and Service Delivery to Rebuild Trust in Government.”  The portion of the executive order that addresses health care directs the Secretary of Health and Human Services to:
    • continue to design and deliver new, personalized online tools and expanded customer support options for Medicare enrollees;
    • strengthen requirements for maternal health quality measurement, including measuring perinatal quality and patient care experiences, and evaluating the measurements by race and ethnicity to aim to better identify inequities in maternal health care delivery and outcomes;
      to the maximum extent permitted by law, support coordination between benefit programs to ensure applicants and beneficiaries in one program are automatically enrolled in other programs for which they are eligible;
    • to the maximum extent permitted by law, support streamlining State enrollment and renewal processes and removing barriers, including by eliminating face-to-face interview requirements and requiring prepopulated electronic renewal forms, to ensure eligible individuals are automatically enrolled in and retain access to critical benefit programs;
    • develop guidance for entities regulated pursuant to the Health Insurance Portability and Accountability Act (HIPAA) on providing telehealth in compliance with HIPAA rules, to improve patient experience and convenience following the end of the COVID-19 public health emergency;
    • test methods to automate patient access to electronic prenatal, birth, and postpartum health records (including lab results, genetic tests, ultrasound images, and clinical notes) to improve patient experiences in maternity care, health outcomes, and equity.
  • The White House has posted transcripts of December 10 and December 15 briefings given by its COVID-19 response team and public officials.

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has updated its COVID-19 Medicare provider enrollment relief FAQ.  Find the updated FAQ here.  These updates are intended in part to assist both new providers and those that have temporarily expanded their facilities.

Health Policy Update

  • CMS has published a new edition of MLN Connects, its online newsletter of information about Medicare payments.  The latest edition includes articles about the two percent Medicare sequester that Congress recently delayed, changes in Medicare Advantage monoclonal antibody claims that take effect on January 1, changes in telehealth fees for originating sites, payments for opioid treatments, and more.  Go here to see the latest edition of MLN Connects.
  • CMS has sent a letter to state Medicaid directors to help them understand new requirements related to the Consolidated Appropriations Act of 2021, which established new requirements for state Medicaid programs, including new reporting requirements for non-disproportionate share hospitals (Medicaid DSH) supplemental payments and a change in the methodology for calculating the hospital-specific DSH limit.   Find that letter here.
  • CMS has sent a letter to state Medicaid directors urging them to encourage hospitals to consider implementation of evidence-based best practices for the management of obstetric emergencies, along with interventions to address other key contributors to maternal health disparities, to support the delivery of equitable, high-quality care for all pregnant and postpartum individuals.  The letter reminds Medicaid directors that beginning with October 1, 2021 discharges, CMS adopted a new structural quality measure for the Hospital Inpatient Quality Reporting (IQR) Program that asks hospitals to attest to whether they participate in a state-wide and/or national maternal safety quality collaborative and whether they have implemented patient safety practices or bundles to improve maternal outcomes.  Find the CMS letter here.  CMS has reinforced this message with this news release.

Department of Health and Human Services

Health Policy Update

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has published a discussion paper about 3D printing medical devices at the point of care, such as hospitals and doctors’ offices.  The purpose of the paper is to gather feedback from the public to inform future policy development.  Find the FDA announcement here and the discussion paper here.  The deadline for submitting comments is February 8.

National Institutes of Health

  • The percentage of adolescents reporting substance use decreased significantly in 2021, according to the latest results from the NIH’s “Monitoring the Future” survey of substance use behaviors and related attitudes among eighth, 10th, and 12th graders in the United States.  In line with continued long-term declines in the use of many illicit substances among adolescents previously reported by the Monitoring the Future survey, these findings represent the largest one-year decrease in overall illicit drug use reported since the survey began in 1975.   Learn more from this NIH news release.

Medicare Payment Advisory Commission (MedPAC)

  • Members of the Medicare Payment Advisory Commission met virtually last week.  Among the subjects MedPAC commissioners and staff discussed were hospital inpatient services, hospital outpatient services, physician services, ambulatory surgical center services, outpatient dialysis, hospice care, skilled nursing facilities, home health, inpatient rehabilitation facilities, and long-term-care hospitals.  Go here to find the meeting presentations on these subjects and go here to see a transcript of the meetings.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • Members of the Medicaid and CHIP Payment and Access Commission met virtually last week.  Among the subjects MACPAC commissioners and staff discussed were directed payments in Medicaid managed care, “money follows the person” program residency criteria, monitoring access to care for Medicaid beneficiaries, behavioral health services, health equity, and nursing facility staffing issues.  For a summary of the meeting and links to the presentations made during the two days of meetings, go here.
  • MACPAC has released the 2021 edition of the MACStats:  Medicaid and CHIP Data Book, with updated data on national and state Medicaid CHIP enrollment, spending, benefits, and beneficiaries’ health, service use, and access to care.  Find this year’s data book here.

Government Accountability Office (GAO)

  • The CARES Act, the Consolidated Appropriations Act of 2021, and the American Rescue Plan all appropriate funds to address behavioral health challenges created by the COVID-19 pandemic and the CARES Act requires the GAO to report on the challenges these funds are addressing and the effect they are having.  The GAO’s findings can be found in its new report “Behavioral Health and COVID-19:  Higher Risk Populations and Related Federal Relief Fund.  Find a summary of the report here and the full report here.

MedPAC Meets

The government agency that advises Congress on Medicare payment matters met publicly in Washington, D.C. last week.

During the virtual meeting, members of the Medicare Payment Advisory Commission discussed and debated future Medicare payments for:

  • hospital inpatient services
  • hospital outpatient services
  • physician services
  • ambulatory surgical center services
  • outpatient dialysis
  • hospice care
  • skilled nursing facilities
  • home health
  • inpatient rehabilitation facilities
  • long-term-care hospitals

MedPAC is an independent congressional agency that advises Congress on issues involving Medicare.  While its recommendations are not binding on either Congress or the administration, MedPAC is highly influential in governing circles and its recommendations often find their way into legislation, regulations, and new public policy.  Because so many patients of community safety-net hospitals are insured by Medicare, MedPAC’s deliberations are especially important to those hospitals.

For a look at the agenda for the two-day meeting and to find the presentations for each of these subjects, go here.

Federal Health Policy Update for Wednesday, December 1

The following is the latest health policy news from the federal government as of 3:00 p.m. on Wednesday, December 1.  Some of the language used below is taken directly from government documents.

Omicron Variant

  • The CDC has confirmed the first case of the COVID-19 omicron variant on U.S. soil.  Learn more from this CDC news release.

Health Care Employee Vaccine Mandate

COVID-19

  • A federal court has issued a preliminary injunction blocking enforcement of the federal government’s requirement that health care workers receive COVID-19 vaccines by December 6.  Find the court’s ruling here.  The ultimate ruling will be made by a higher court.

No Surprises Act

  • CMS has released a series of documents addressing implementation of the No Surprises Act, the surprise medical billing law that takes effect on January 1.  Go here for a link to a zip file of those documents.
  • A reminder:  stakeholder comments on the most recent regulation implementing the No Surprises Act are due this coming Monday, December 6,

The White House

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has issued guidance to inform Medicare Part D sponsors of permissible flexibilities during the COVID-19 public health emergency related to oral antiviral drug(s) for COVID-19 if such drug(s) become available under FDA emergency use authorization and are procured by the federal government.  Find that guidance here.
  • CMS has updated its compendium of Medicare emergency declaration blanket waivers for health care providers with two changes:  one, on page 21, addresses requirements for individuals employed as directors of food and nutrition services in long-term-care facilities and another, on page 33, alters Medicare ground ambulance data collection reporting requirements.  Find the revised blanket waivers document here.

Health Policy Update

  • CMS has published a request for public comments on potential changes in the requirements that transplant programs, organ procurement organizations, and end-stage renal disease facilities must meet to participate in the Medicare and Medicaid programs.  Learn more about what CMS seeks in this Federal Register notice.  Stakeholder comments are due in 60 days.
  • CMS has announced that it will not move forward with the Seriously Ill Population component of its Primary Care First Model.  That component was designed to have advanced primary care practices coordinate care for high-need, seriously ill beneficiaries.  After review, CMS concluded that the program’s outreach methodology was unlikely to result in sufficient beneficiary participation to allow for model evaluation.  Learn more from this CMS announcement.
  • CMS has published two documents addressing Medicaid and CHIP in the post-COVID-19 world:  “Strategies States and the U.S. Territories Can Adopt to Maintain Coverage of Eligible Individuals as They Return to Normal Operations” and “Connecting Kids to Coverage: State Outreach, Enrollment and Retention Strategies.”
  • CMS has posted the latest edition of MLN Connects, its online publication addressing Medicare payment matters.  This edition includes items on new 2022 web pricers for inpatient prospective payment system hospitals, inpatient rehabilitation facilities, and long-term-care hospitals; information about the 2022 physician fee schedule rule; news about telehealth originating site facility payments; information about disproportionate share hospital (DSH) payments; and more.  Go here for the new MLN Connects.

Department of Health and Human Services

Health Policy Update

  • HHS has launched a website for the HHS 405(d) Aligning Health Care Industry Security Approaches Program.  The purpose of the site is to provide the health care and public health sectors “…with useful, impactful, and vetted resources, products, videos, and tools that help raise awareness and provide cybersecurity practices, which drive behavioral change and move toward consistency in mitigating the most relevant cybersecurity threats to the sector.”  The website features health care-focused resources such as cybersecurity posters and infographics, installments of a bi-monthly newsletter, webinar recordings, and threat-specific products to support cybersecurity awareness and training.  Learn more from this HHS news release and go here to find the new site.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has updated its guidance on the use of the monoclonal antibodies amlanivimab and etesevimab when administered together, expanding their authorized use to all U.S. states and territories.  Find that guidance here.
  • The FDA has issued emergency use authorization for the emergency use of the unapproved monoclonal antibody product sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive results of direct COVID-19 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death.  Go here for an FDA fact sheet on the drug’s use.
  • The FDA has issued a statement outlining its efforts to investigate and address the potential impact of the COVID-19 omicron variant.  Find that statement here.

Stakeholder Events

CMMI – The Value-Based Insurance Design Health Equity Business Case for Medicare Advantage Organizations – December 2

The Center for Medicare and Medicaid Innovation (CMMI) is sponsoring a series of webinars for current and potential Medicare Advantage Organization participants in its Value-Based Insurance Design Model.  The first webinar in the series will provide an overview of the model’s health equity incubation sessions effort, articulate a business case for Medicare Advantage organizations to leverage Value-Based Insurance Design Model components to address health inequities in their member populations, and provide specific guidance and clarification on the full extent of health equity-focused flexibilities that fall under the model’s waiver authority.  The first webinar will be held on Thursday, December 2 at 2:30 p.m. (eastern).  Go here for more information about the webinar and to register to participate.

Center for Medicare and Medicaid Innovation – Roundtable on Health Equity Strategy – December 8

CMMI will hold a roundtable event on Wednesday, December 8 at 1:30 p.m. (eastern) to discuss how it can carry out its strategic objective of advancing health equity.  The agency also invites written comments on the subject.  For further information about the roundtable and to register to participate, go here.

CDC – Molecular Approaches for Clinical and Public Health Applications to Detect Influenza and COVID-19 Viruses – December 9

The CDC will hold a webinar on Thursday, December 9 to share with clinicians information about molecular approaches for clinical and public health applications to detect the influenza virus and COVID-19.  Go here to learn more about the webinar and how to participate.

MEDPAC – commission meeting – December 9-10

Members of the Medicare Payment Advisory Committee will meet virtually on December 9 and 10.  Information about how to join the meeting will be forthcoming; when it is, that information will be posted here.

MedPAC Looks at Outpatient Payments

The question of whether Medicare should pay different rates for outpatient services delivered in different types of settings was very much on the minds of Medicare Payment Advisory Commission members during their public meetings last week.

The issue has been around for a while:  are there valid reasons for some facilities to be paid more for certain outpatient services than other facilities?  Or should the payment rate for a given service be the same regardless of where that service is delivered?  Does the site of the service matter – or should it?

At issue are Medicare payments made to private physician offices, hospital outpatient departments, and ambulatory surgical centers and whether they should be adjusted based on some of the underlying costs associated with those facilities or the matter of who owns them – or whether a service is a service that should be reimbursed at the same rate regardless of where it is delivered.  Underlying this issue is whether providers should be compensated for such services through Medicare’s outpatient prospective payment system or its physician fee schedule.

It matters where MedPAC ultimately comes down on this issue.  While the agency’s primary role is to advise Congress on Medicare payment issues, its views are highly respected in health policy circles and often find their way into new public policies.

Learn more about the issues involved and what MedPAC commissioners think about them in the MedPage Today article “Should Medicare Pay the Same Amount Regardless of Where a Service Is Provided?

MedPAC Discusses Post-COVID Telehealth

Should Medicare continue to encourage the use of telehealth when the COVID-19 pandemic ends?

Should it continue to pay for telehealth when the there is no “tele” in the service and it is audio only?

And should Medicare pay different rates for visits in person, telehealth visits, and audio-only (that is, telephone) visits?

These were among the questions addressed by members of the Medicare Payment Advisory Commission during their public meetings last week.

Members also discussed the need for further analysis of the effectiveness of telehealth and audio-only visits, how to identify audio-only visits on Medicare claims, how to collect data from home health agencies and hospices, which are not required to submit telehealth data, and more.

Learn more about what MedPAC is thinking about the use of telehealth in the future in the MedPage Today article “Medicare Advisors Consider Post-Pandemic Telehealth Pay Policy.”

Federal Health Policy Update for Thursday, November 4

The following is the latest health policy news from the federal government as of 2:45 p.m. on Thursday, November 4.  Some of the language used below is taken directly from government documents.

New Federal Vaccination Requirements

CMS has unveiled its new COVID-19 vaccine requirements for health care providers that receive reimbursement from the federal government.  The highlights include:

  • CMS is requiring COVID-19 vaccination of eligible staff at health care facilities that participate in the Medicare and Medicaid programs.
  • The staff vaccination requirement applies to the following Medicare and Medicaid-certified provider and supplier types:  ambulatory surgery centers, community mental health centers, comprehensive outpatient rehabilitation facilities, critical access hospitals, end-stage renal disease facilities, home health agencies, home infusion therapy suppliers, hospices, hospitals, intermediate-care facilities for individuals with intellectual disabilities, clinics, rehabilitation agencies, public health agencies as providers of outpatient physical therapy and speech-language pathology services, psychiatric residential treatment facilities, Programs for All-Inclusive Care for the Elderly Organizations (PACE), rural health clinics/federally qualified health centers, and long-term care facilities.
  • Facilities covered by this regulation must establish a policy ensuring that all eligible staff have received the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine prior to providing any care, treatment, or other services by December 5, 2021.  All eligible staff must have received the necessary shots to be fully vaccinated – either two doses of Pfizer or Moderna or one dose of Johnson & Johnson – by January 4, 2022.  The regulation also provides for exemptions based on recognized medical conditions or religious beliefs, observances, or practices.
  • The regulation addresses who, among health care facilities’ employees, are subject to this requirement.  These requirements, it notes, must apply to the following facility staff, regardless of clinical responsibility or patient contact and including all current staff as well as any new staff who provide any care, treatment, or other services for the facility and/or its patients:  facility employees; licensed practitioners; students, trainees, and volunteers; and individuals who provide care, treatment, or other services for the facility and/or its patients under contract or other arrangement.
  • These requirements are not limited to those staff who perform their duties within a formal clinical setting, as many health care staff routinely care for patients and clients outside of such facilities, such as home health, home infusion therapy, hospice, PACE programs, and therapy staff.
  • Further, there may be staff that primarily provide services remotely via telework that occasionally encounter fellow staff, such as in an administrative office or at an off-site staff meeting, who will themselves enter a health care facility or site of care for their job responsibilities.  CMS has concluded that it is necessary to require vaccination for all staff that interact with other staff, patients, residents, clients, or PACE program participants in any location, beyond those who physically enter facilities, clinics, homes, or other sites of care.
  • Transplant centers, psychiatric hospitals, and swing beds are governed by the infection control conditions of participation for hospitals and are thus subject to the staff vaccination requirements issued in this rule.
  • Individuals who provide services 100 percent remotely, such as fully remote telehealth or payroll services, are not subject to the vaccination requirements of this rule.  Providers should identify and monitor these individuals as a part of implementing the policies and procedures of this rule.
  • The rule encompasses administrative staff, facility leadership, volunteer or other fiduciary board members, housekeeping and food services staff, and others.  Regulators considered excluding individual staff members who are present at the site of care less frequently than once a week from these vaccination requirements but were concerned that this might lead to confusion or fragmented care, so any individual who performs their duties at any site of care, or has the potential to have contact with anyone at the site of care, including staff or patients, must be fully vaccinated.
  • Regulators noted that many infrequent services and tasks performed in or for a health care facility are conducted by “one off” vendors, volunteers, and professionals.  Providers and suppliers are not required to ensure the vaccination of individuals who infrequently provide ad hoc non-health care services (such as annual elevator inspection), delivery, or repair personnel.
  • When determining whether to require COVID-19 vaccination of an individual who does not fall into the categories established by this rule, facilities are told to consider frequency of presence, services provided, and proximity to patients and staff.  For example, a plumber who makes an emergency repair in an empty restroom or service area and correctly wears a mask for the entirety of the visit may not be an appropriate candidate for mandatory vaccination. On the other hand, a crew working on a construction project whose members use shared facilities (restrooms, cafeteria, break rooms) during their breaks would be subject to these requirements because they are using the same common areas used by staff, patients, and visitors.
  • To learn more, please consult the following resources:
  • OSHA has announced a new emergency temporary standard to protect more than 84 million workers from the spread of COVID-19 on the job.  Under this standard, covered employers (those with 100 or more employees) must develop, implement, and enforce a mandatory COVID-19 vaccination policy unless they adopt a policy requiring employees to choose either to be vaccinated or to undergo regular COVID-19 testing and wear a face covering at work.  Learn more from this OSHA news release and the agency’s formal Emergency Testing Standard, as published in the Federal Register.

New Medicare Regulations

CMS has released a number of final Medicare regulations.  The following are those final rules and links to additional information about them.

  • Hospital outpatient prospective payment system, ambulatory surgical center prospective payment system, price transparency, and radiation oncology model rule – changes include a two percent rate increase; restoration of the inpatient-only procedure list and most procedures that were removed from that list last year; continuation of 340B payments at average sale price minus 22.5 percent; changes in the hospital price transparency rule that leave hospitals with more than 30 beds subject to fines of up to $5500 a day or more than $2 million a year; changes in the quality reporting program, including a measure for COVID-19 vaccination rate among health care workers; and some changes in the Radiation Oncology Model program that begins on January 1, 2022, including invoking its “Extreme and Uncontrollable Circumstances Policy” for the program.  To learn more, see the following resources:
  • For more on the “Extreme and Uncontrollable Circumstances Policy” and its application to the Radiation Oncology Model, go here and scroll down.
  • Physician fee schedule – changes include an overall reduction of nearly nine percent in physician payments; a reduction of the conversion factor from the current $34.89 to $33.59; and provisions for the expanded use of telehealth.  To learn more, see the following resources:
  • Home health prospective payment system – changes include a 3.2 percent rate increase, changes in the Medicare conditions of participation, and provisions for expanded use of telehealth.  To learn more, see the following resources:
  • CMS has issued a final rule that updates payment rates under the End-Stage Renal Disease (ESRD) Prospective Payment System for renal dialysis services furnished to beneficiaries on or after January 1, 2022.  This rule also finalizes updates to the Acute Kidney Injury program dialysis payment rate for renal dialysis services furnished by ESRD facilities.  It also finalizes modifications to the ESRD Treatment Choices Model policies to encourage certain health care providers to reduce disparities in rates of home dialysis and kidney transplants among ESRD patients with lower socioeconomic status.  To learn more, see the following resources:

The White House

Congress

  • Yesterday, House Democrats released the text of its reconciliation bill, H.R. 5376 – the Build Back Better Act.  This bill includes a provision that provides a glide-path to ending the enhanced 6.2% Medicaid federal matching percentage established by the Families First Coronavirus Response Act passed in March last year.  The enhanced FMAP would be phased out as follows:
    • April 1, 2022, the enhanced FMAP lowered  to 3.0 percentage points;
    • July 1, 2022, enhanced FMAP lowered to 1.5 percentage points;
    • October 1, 2022, enhanced FMAP expires.
  • House Speaker Nancy Pelosi hopes the House will vote on the domestic spending reconciliation bill as early as this evening, to be followed by a vote on the bipartisan, Senate-passed infrastructure bill on Friday.  House Democrats have continued to negotiate changes in the reconciliation bill to gain more support, though it is unclear whether those changes have persuaded enough Democrats in the House to support the bill at this time.  Also unclear is whether the House bill will comply with the Senate’s procedural rules or whether this bill will have the support of all 50 Democratic senators.

Provider Relief Fund:  Phase 3 Payment Reconsideration

  • The Health Resources and Services Administration (HRSA) is accepting requests for reconsideration from providers that believe their Provider Relief Fund Phase 3 payments were incorrectly calculated.  Providers may not revise or correct their submitted application and the reconsideration will address only the calculation itself and not objections to the calculation methodology.  Go here for further information.  The deadline for submitting requests for reconsideration of Phase 3 payments is November 12.

Department of Health and Human Services

Health Policy News

  • HHS has proposed eliminating the “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET) regulation, adopted in January of this year, that would have eliminated department regulations after ten years unless HHS took specific action to renew them.  In proposing to reverse the rule, HHS cited its previous failure to consider stakeholder objections to the rule, the burden it would place on the agency, and its potentially negative effect on medically vulnerable populations.  See HHS’s proposed rule overturning the SUNSET regulation in this Federal Register notice.
  • HHS has awarded $3.37 billion in relief funds through the Low Income Home Energy Assistance Program (LIHEAP) to help low-income individuals and families afford home heating costs this winter and cover unpaid utility bills.  This supplements $4.5 billion in LIHEAP funds from the American Rescue Plan Act that were released in May.  Learn more about this new LIHEAP funding and how interested parties can apply for assistance in this HHS news release.
  • HRSA has issued an interim update to its strategic plan to ensure alignment with the administration’s and HHS’s priorities, such as their emphasis on health equity, and the expansion of HRSA’s program responsibilities.  Go here to learn about the updated interim plan.
  • HRSA has opened its application process for three of its loan repayment programs with the support of an additional $800 million made available through the American Rescue Plan.  Eligible clinicians providing primary medical, dental, behavioral health care services, or evidence-based substance use disorder treatment can qualify for loan repayment of up to:
  • $50,000 for the NHSC Loan Repayment Program
  • $75,000 for the NHSC Substance Use Disorder Workforce Loan Repayment Program
  • 100,000 for the NHSC Rural Community Loan Repayment Program

Go here to learn more about eligible clinicians.  Applications are due December 16.

  • HHS’s Indian Health Service has announced $46.4 million in funding opportunities to address suicide, domestic violence, and substance abuse and for support for an integrative approach to the delivery of behavioral health services for American Indians and Alaska Natives.  Go here to learn more about the funding opportunities.  Applications are due February 2.

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has reminded eligible consumers and providers that coverage for COVID-19 vaccines for children from the ages of five to 11 is available without cost-sharing under Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and in the commercial market.  Under the terms of the CDC’s COVID-19 Vaccination Program Provider Agreement, health care providers and other entities administering COVID-19 vaccines must agree not to deny anyone a COVID-19 vaccination based on their health coverage status and also must agree to administer COVID-19 vaccines at no out-of-pocket cost to recipients.  Learn more from this CMS news release.
  • CMS has posted a quick start guide to CLIA certification for COVID-19 testing in the workplace and an accompanying FAQ.

Health Policy News

  • CMS has extended two deadlines affecting hospitals that participate in its Hospital Inpatient Quality Reporting Program and/or the Medicare Promoting Interoperability Program.  As described in this CMS notice,
  • The deadline for the submission of electronic clinical quality measure (eCQM) data for the calendar year 2021 reporting period, pertaining to the FY 2023 payment determination, has been changed from Monday, February 28, 2022 to Thursday, March 31, 2022 at 11:59 p.m. Pacific time.
  • The Medicare Promoting Interoperability Program attestation deadline for eligible hospitals and critical access hospitals has been changed from Monday, February 28, 2022 to Thursday, March 31, 2022 at 11:59 p.m. Pacific time.
  • CMS has posted the latest edition of MLN Connects, its online newsletter.  Included in the new release are articles about changes for Medicare Advantage plan claims for COVID-19 vaccines and monoclonal antibodies that will take effect on January 1, 2022; changes in Medicare billing practices; a new web-based training program on post-acute care quality reporting programs; and more.  Go here to see the latest edition of MLN Connects.
  • CMS has released an updated fact sheet, based on recent legislative changes, to help states and advocacy organizations understand what health coverage options are available to Afghan evacuees.  Find that fact sheet here.

Food and Drug Administration

Centers for Disease Control and Prevention

National Institutes of Health

  • The NIH’s Rapid Acceleration of Diagnostics initiative has announced the launch of the “When To Test Calculator for Individuals,” a companion to the version for organizations introduced last winter.  By responding to just a few prompts, the new online individual impact calculator indicates whether a person should get a test and when.  The calculator includes answers to frequently asked questions and links to resources on testing strategies and on obtaining supplies, including home tests.  Learn more from this NIH announcement.
  • The NIH will support a four-year follow-up study on the potential long-term effects of COVID-19 on women infected with the virus during pregnancy.  The study also will follow their offspring for any potential long-term effects.  Learn more from this NIH news release.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has updated “Payment Basics,” its series of brief overviews of how Medicare’s payment systems function.  The agency produces Payment Basics as a resource for policy-makers and others to better understand how Medicare pays for health care services.  Much of the update reflects COVID-19-related payment changes.  Find the series here.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • MACPAC met on Thursday, October 28 and Friday, October 29.  For a summary of the meeting and links to the agenda and presentations made during the meeting, go here.
  • MACPAC has published a new issue brief that describes the use and oversight of upper-payment limit (UPL) payments for hospitals, nursing facilities, and physicians based on its review of provider-level data submitted by states to CMS to demonstrate compliance with UPL requirements.  The brief concludes with a discussion of current policy issues, including the new requirement for CMS to make provider-level UPL data publicly available.  Find the brief here.

Government Accountability Office (GAO)

  • The GAO recently evaluated the effectiveness of the federal government’s organization of the distribution of COVID-19 vaccines and its communication about those efforts and has published its findings and recommendations in the new report “COVID-19:  HHS Agencies’ Planned Reviews of Vaccine Distribution and Communication Efforts Should Include Stakeholder Perspectives.”  Find a summary of the report here and the full report here.

Congressional Research Service

Stakeholder Events

Medicare Payment Advisory Commission (MedPAC) – November 8 and 9

MedPAC will hold virtual meetings on November 8 and 9.  For information about times, agenda, and how to join the meeting go here.

CMS – Medicare Clinical Laboratory Fee Data Collection and Reporting Webinar – November 10

CMS will hold a webinar on Medicare clinical laboratory private payer data collection and reporting on Wednesday, November 10 at 3:30 p.m. (eastern).  Go here to register to participate.

HHS – Monoclonals and More:  Issues and Opportunities with Early COVID-19 Treatment Options – November 12

HHS’s Office of the Assistant Secretary for Preparedness and Response will hold a webinar on COVID-19 treatment with monoclonal antibodies on Friday, November 12 at 12:30 p.m. during which it will address some of the most current recommendations for use of monoclonal antibodies, upcoming therapies, and the challenges and opportunities that new therapies may pose in conjunction with monoclonal antibodies and other treatments (e.g., prioritization and distribution).  Speakers also will highlight operational principles for a scaled strategy for use of these therapeutics in a scarce resource situation.  For more information about the webinar and to register, go here.

CMS – COVID-19 Vaccines and Rural Communities – November 15

CMS will hold a webinar on COVID-19 vaccines and rural communities for its community providers and partners working in rural areas.  Go here for further information about the webinar and to register to participate.

CDC – Antibiotic Prescribing and COVID-19 – November 18

The CDC will hold a webinar titled “What Clinicians, Pharmacists, and Public Health Partners Need to Know About Antibiotic Prescribing and COVID-19” on Wednesday, November 18 at 2:00 p.m. (eastern).  Go here for information about the webinar, the presenters, and how to participate.

Federal Health Policy Update for Monday, October 25

The following is the latest health policy news from the federal government as of 2:30 p.m. on Monday, October 25.  Some of the language used below is taken directly from government documents.

NASH Advocacy:  MedPAC and Safety-Net Hospitals

On the heels of a recent meeting of the Medicare Payment Advisory Commission (MedPAC) during which commission members discussed the challenges inherent in attempting to identify safety-net hospitals, NASH has written to the agency to suggest that it consider a different approach to addressing that matter.  In the letter, NASH suggests that MedPAC urge Medicare to look not at individual hospitals and what kinds of patients they serve but to focus instead on vulnerable communities and then to identify the hospitals that are caring for meaningful proportions of the residents of those communities.  Go here to see NASH’s letter to MedPAC.  In response to this letter, MedPAC scheduled a meeting with NASH to discuss this concept.

NASH Advocacy:  Surprise Billing Regulation

Representatives Suozzi (D-NY), Wenstrup (R-OH), Ruiz (D-CA), and Bucshon (R-IL) are leading a bi-partisan congressional sign-on letter to HHS Secretary Becerra and others, urging the administration to revise the Surprise Billing, Part II interim final rule’s (IFR) implementation of the independent dispute resolution (IDR) process.

The letter states that

…we urge you to revise the IFR to align with the law as written by specifying that the certified IDR entity should not default to the median in-network rate and should instead consider all of the factors outlined in the statute without disproportionately weighting one factor.

NASH is listed among the supporters of this letter.

Action required:  NASH members should contact their House members today to ask them to sign on to the Suozzi-Wenstrup-Ruiz-Bucshon letter to support the successful implementation of Congress’s surprise billing ban.  The deadline for representatives to sign onto the letter is this Friday, October 29.

If you would like more information about the letter or if you need contact information for your representatives, contact Kate Finkelstein.

Provider Relief Fund:  Deadline for Submission is Tuesday, October 26

  • The Health Resources and Services Administration (HRSA) will accept applications for $25.5 billion in health care relief funds until October 26.  Go here for further information.
  • HRSA has modified some of the terms for applying for assistanceAll applicants must complete the first step of the application process (i.e., submitting their Tax Identification Number (TIN) and associated information for Internal Revenue Service (IRS) validation no later than October 26, 2021 at 11:59 PM EST.  The required IRS validation that occurs after completion of the first step may take a few days.  If an applicant submits their TIN for validation by the October 26, 2021 deadline and that TIN is subsequently validated by the IRS, the applicant will have until November 3, 2021 at 11:59 PM EST to complete and submit their application.
  • The Provider Relief Fund FAQ has been updated with seven modified or new questions on pages 4, 9, 10 (two questions), 37, and 58 (two questions); all are dated 10/20/2021.  Entities that have received Provider Relief Funds in the past and/or intend to apply for Phase 4 funds should review these changes carefully.

The White House

  • In anticipation of the FDA’s independent advisory committee meeting on October 26 and the CDC’s independent advisory committee meeting on November 2-3, the administration has unveiled a plan to ensure that if a vaccine is authorized for children ages 5-11 it is quickly distributed and made conveniently and equitably available to families across the country.  Learn more from this White House fact sheet.
  • The White House has posted transcripts of the October 20 and October 22 press briefings given by its COVID-19 response team and public officials.

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has issued guidance to states about the statutory requirement for them to cover COVID-19-related treatment without cost-sharing in Medicaid and CHIP for many seniors, low-income adults, pregnant women, children, and people with disabilities who receive health coverage through these programs.  This coverage includes care for conditions that could complicate the treatment of COVID-19 in patients who are presumed positive for the virus or have been diagnosed with COVID-19.  Find a news release about the guidance here and find the guidance itself here.
  • CMS has posted a new edition of MLN Connects, its online newsletter.  This latest edition includes features on new/modifications of the place of service codes for telehealth, a prescriber’s guide to Medicare prescription drug opioid policies, and more.  Go here to find these and other items.
  • In a separate, special edition of MLN Connects, CMS presents new Medicare rates and billing information for Moderna and Johnson & Johnson booster vaccines.
  • The CMS Innovation Center has published a document that shares its strategic direction for the coming years.  Driving Health System Transformation – A Strategy for the CMS Innovation Center’s Second Decade reviews the lessons the agency has learned over the past ten years and lays out its objectives for the next ten.  Find it here.
  • CMS’s Center for Medicare and Medicaid Innovation has posted the fourth evaluation report and performance year 5 (2020) financial and quality results for its Next Generation ACO Model.  Find the report by going here and scrolling down to “Performance Year 5 (2020 (XLS).”
  • CMS’s “Medicare & You” handbook is now available in Chinese, Korean, and Vietnamese.  Go here for the agency’s announcement and links to the new handbooks.

Department of Health and Human Services

Health Policy News

  • HHS is awarding $797.5 million in American Rescue Plan funding to support survivors of domestic violence and sexual assault and their children.  The funds will cover COVID-19 testing, vaccines, mobile health units, and other support for domestic violence services programs and increase support for sexual assault service providers and culturally specific services.  Learn more about the new spending and how it will be distributed in this HHS news release and additional program resources.
  • HHS proposes repealing two final rules:  “Department of Health and Human Services Good Guidance Practices,” published in the Federal Register on December 7, 2020; and “Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions,” published in the Federal Register of January 14, 2021, maintaining that “…they create unnecessary hurdles that hinder the Department’s ability to issue guidance, bring enforcement actions, and take other appropriate actions that advance the Department’s mission.”  Learn more about the rules that would be repealed and HHS’s rationale for doing so in this Federal Register notice.

Centers for Disease Control and Prevention

  • The CDC has taken a series of actions to address COVID-19 booster vaccines, deciding that:
    • The use of a single booster dose of the Moderna COVID-19 vaccine that may be administered at least six months after completion of the primary series to individuals 65 years of age and older; 18 through 64 years of age at high risk of severe COVID-19; and 18 through 64 years of age with frequent institutional or occupational exposure to COVID-19.
    • The use of a single booster dose of the Johnson & Johnson vaccine may be administered at least two months after completion of the single-dose primary regimen to individuals 18 years of age and older.
    • Each of the available COVID-19 vaccines may be use as a booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.  This is now being referred to by many as “mixing and matching.”
    • A single booster dose of the Pfizer vaccine may be administered at least six months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to COVID-19.

Stakeholder Events

CDC – Information about Recent Updates to CDC’s Recommendations for COVID-19 Boosters – October 26

On Tuesday, October 26 the CDC will provide an overview for clinicians of the most recent recommendations for administering COVID-19 booster vaccines and updates about the latest recommendations and clinical considerations for administering those boosters.  Go here for further information about the webinar and how to participate.

CDC – Pediatric COVID-19 Vaccines – November 4

The CDC will hold a webinar on Thursday, November 4 to provide an overview of its recommendations and clinical considerations for administering COVID-19 vaccines to children between the ages of five and eleven years old.  Go here for further information about the webinar and how to participate.

HHS – Monoclonals and More:  Issues and Opportunities with Early COVID-19 Treatment Options – November 12

HHS’s Office of the Assistant Secretary for Preparedness and Response will hold a webinar on COVID-19 treatment with monoclonal antibodies on Friday, November 12 at 12:30 p.m. during which it will address some of the most current recommendations for use of monoclonal antibodies, upcoming therapies, and the challenges and opportunities that new therapies may pose in conjunction with monoclonal antibodies and other treatments (e.g., prioritization and distribution).  Speakers also will highlight operational principles for a scaled strategy for use of these therapeutics in a scarce resource situation.  For more information about the webinar and to register, go here.